1. Field of the Invention
The present invention relates, generally, to medical devices and medical device manufacturing apparatus and methods. Additionally, the invention relates to holding, compressing, and crimping devices. More particularly, the invention relates to medical stent crimping devices. The invention has particular utility in the medical industry as a device and method for uniformly crimping a balloon expandable or self-expanding metal or non-metallic stents or stent grafts by a hand held apparatus or hand implementable method.
2. Background Information
The state of the art includes various stent crimping devices and methods. The devices include a collet style crimp mechanism, a flat rolling plate style crimp mechanism, loop or coil radial compression (U.S. Pat. No. 6,063,102), a funnel tube style crimping mechanism (U.S. Pat. No. 5,992,000 FIG. 3), a Touhy style silicone elastomeric crimp sleeve (U.S. Pat. No. 6,009,614), and an expandable bladder/elastic tube. The flat rolling plate style crimp mechanism includes an elastomeric surface upon which the stent in place, and a flat plate positioned and adapted to roll over the stent. Weight may be added onto the plate. The rolling action crimps the stent in place somewhat akin to rolling out dough. The expandable bladder is shaped as a sleeve. Fluid is pumped into the bladder to rotatably compress the stent positioned in it. Other U.S. patents directed to stent crimping technology include U.S. Pat. Nos. 6,063,092, 6,051,002, 6,024,737, 6,018,857, 5,951,540, 5,931,851, 5,672,169, 5,672,169 and 5,626,604. These patents provide background information on stent technology in general and are incorporated by reference for that reason.
The known stent crimper devices and methods are believed to have significant limitations and shortcomings. For example, their structure (i.e. bore size in the structure) limits the diameter of the stent. Additionally, they are not able to use a simple process to satisfy the tolerance demands for certain medical applications. For example, they may not be able to accurately, consistently and uniformly crimp the stent in a single step. This is particularly true of stents with small diameters. For this and other reasons, a need exists for the present invention.
U.S. patent application Ser. No. 09/877,469, filed Jun. 8, 2001, entitled STENT CRIMPING APPARATUS AND METHOD, filed Jun. 8, 2001 discloses table top, powered and automatic stent crimping apparatus and methods.
This invention provides a hand held stent crimper device and method which are believed to fulfil the need and to constitute an improvement over the background technology. The device and method of the present invention makes it possible through a simple process to crimp a balloon expandable or self-expanding metal or non-metallic intravascular or other anatomically placed stents. The present invention does not require a fixed bore size (I.D.) to obtain the final crimped stent profile. The present invention can be designed to crimp operably receive stents having diameters from 12 mm (0.47 in.) to near zero. It has been found that, to optimize the present invention to crimp coronary stents, the device should be designed to handle stents between 5 mm to 0.5 mm. The present invention is capable of holding tolerances to 0.005″ while providing a uniform extended crimp of between 2 mm (0.08 in.) and 100 mm (3.94 in.) in length.
Benefits of this technology, in general, include a reduced cycle time, reduced machine size, repeatability of the crimped stent diameter, security of the crimped stent, and the elimination of a fixed bore size (I.D.) during the crimp process.
The stent crimping apparatus and method of this invention are particularly useful for engineers, clinical research workers, and pre-clinical catheterization laboratory workers.
All US patents and patent applications, and all other published documents mentioned anywhere in this application are incorporated by reference in their entirety.